ES-160 ES-160

GUDID 04983087008496

Electro Stimulator Therapy Unit

ITO CO., LTD.

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• Primary Device ID: 04983087008496
• NIH Device Record Key: 947bf6ee-f48b-4ed2-a4aa-a2d9d9404727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ES-160
• Version Model Number: ES-160
• Catalog Number: ES-160
• Company DUNS: 690637194
• Company Name: ITO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04983087008496 [Primary]
GS1	24983087008490 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051020

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

Devices Manufactured by ITO CO., LTD.

• 04983087012394 - D function: 2021-09-17 Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
• 04983087008403 - ES-130: 2019-10-23 Electro Acupuncture Therapy Unit
• 04983087008496 - ES-160: 2019-10-23Electro Stimulator Therapy Unit
• 04983087008496 - ES-160: 2019-10-23 Electro Stimulator Therapy Unit
• 04983087007932 - TM-400: 2018-07-06 Traction Device